Department of Health and Human Services May 23, 2014 – Federal Register Recent Federal Regulation Documents

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting June 10-11, 2014. The meeting is open to the public. However, pre- registration is required for both public attendance and public comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac. Participants may also register by emailing nvpo@hhs.gov or by calling 202-690-5566 to provide your name, organization, and email address.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of February 5, 2014, entitled ``Sanitary Transportation of Human and Animal Food'' and its information collection provisions. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

This document corrects a notice that was published in the Federal Register on April 25, 2014 (79 FR 22975). The time and date should read as follows: Time and Date: 10 a.m.-5 p.m., June 17, 2014 (Closed).

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for INLYTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB.'' The guidance announced in this document discusses regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA's jurisdiction is transferred from one IRB to another IRB. The guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred.

This notice announces the application of AABB for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AABB deeming authority for a period of 6 years. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program.